Apparatus and method for treating and dispensing a material into tissue

ABSTRACT

A method for administering a therapeutic is provided. In various embodiments, the method includes providing a handheld dispensing apparatus comprising a housing defining a chamber, a material treatment module in material communication with the chamber, an outlet in material communication with the chamber, and a needle in material communication with the outlet for releasing the material from the housing. The method includes collecting a precursor material in the chamber, activating the material treatment module, treating the precursor material collected in the chamber with the material treatment module to create a treated material, positioning the needle in a body, and dispensing the treated material out of the apparatus into the body.

RELATED APPLICATIONS

This application is a divisional of, and claims priority to, U.S. patentapplication Ser. No. 11/616,041 entitled “Apparatus and Method forAdministering a Therapeutic Agent into Tissue” and filed on Dec. 26,2006 for Ashok Joshi, et al., which is a continuation-in-part of, andclaims priority to, U.S. patent application Ser. No. 11/193,339 entitled“Apparatus and Method for Administering a Therapeutic Agent into Tissue”and filed on Aug. 1, 2005 for Ashok Joshi, et al. U.S. patentapplication Ser. No. 11/616,041 is also a continuation-in-part of, andclaims priority to, U.S. patent application Ser. No. 10/867,215 entitled“Apparatus and Method for Administering a Therapeutic Agent Into Tissue”and filed on Jun. 15, 2004. These applications are hereby incorporatedby reference.

FIELD OF THE INVENTION

The present invention relates generally to an apparatus foradministering a therapeutic agent into tissue and in particular, for thecreation and administration of a fluidic therapeutic agent into a tissueusing a portable device.

BACKGROUND OF THE INVENTION

Back joint disc or tendon pain is a common and potentially debilitatingailment that affects an estimated 80% of the worldwide population atleast once in a lifetime. In many instances, the cause of the pain canbe attributed to a degenerated intervertebral disc that has furtherdeteriorated into a condition known as disc herniation. This occurs whenthe disc nucleus pulposus extrudes through a tear or fissure in theouter lining of the disk, thereby exerting pressure on spinal nerves.The compression caused by the herniated nucleus leads to inflammationand is directly responsible for the pain felt down the leg (alsoreferred to as sciatica). Available treatments for this type of backpain vary according to the severity of the hernia. If mild, thepatient's condition can be appeased with rest and inactivity for anextended period of time. However, for patients suffering from a severeherniation or who do not respond to non-invasive treatment(pharmacological and/or physical therapy), surgical intervention isoften recommended. With this invasive treatment come severaldisadvantages such as:

i) irreversibility of the procedure

ii) formation of scar tissue

iii) slower recovery time

iv) longer hospital stays

v) risk of infection

Since the late 1950s, many attempts have been made to treat sciatica andlower back pain with minimally invasive percutaneous procedures to avoidsurgery. Well known treatments for example are percutaneous discetomy,percutaneous plasma disc decompression (nucleoplasty), intradiscalelectrothermal therapy (IDET), and percutaneous intradiscalradiofrequency thermocoagulation (PIRT) but the high costs of theseprocedures has kept researchers looking for another alternative. In 1984an Italian orthopedic surgeon named Dr. Cesare Verga proposed the use ofozone/oxygen mixtures to treat the pathology of a herniated disk.

In other situations such as rheumatoid arthritis, osteoarthritis or arepetitive injury through sports or occupation, such as tennis elbow,frozen shoulder, or house maids knee, inflammation can develop betweenthe two surfaces that are involved in allowing joint function, such as atendon and the sheath or lubricated tube in which that tendon moves.Inflammation such as bursitis in the knee shoulder hip, or otheranatomic bursa may benefit from the administration of a therapeuticagent such as oxygen-ozone mixtures or excited, energetic, pure oxygen,this includes epicondylitis, and other tendonitis and bursitis,including the wrist, hand and the tendon sheaths of the hand and wrist.Inflammation can occur at a site where a tendon or a ligament insert tobone or pass through a sheath from trauma, tension, over use or disease.

Inflammation can develop through pathologies of any joint, and these mayagain include the inflammatory arthropatic conditions of rheumatoidarthritis, psoriatic arthritis and the like, or osteoarthritis. Jointsthat may be involved in these processes that are amenable to theadministration of a therapeutic agent such as oxygen-ozone mixtures orexcited, energetic, pure oxygen include the synovial joints such as the,temperomandibular joint, the hip joint, knee joint, ankle joint, elbowjoint or sacro-iliac joint. Vertebral facet and sacro-iliac joints mayalso benefit, inflammatory involvement of joints in the hand, wrist andfeet with rheumatoid arthritis, osteoarthritis or a repetitive injurythrough sports or occupational such as carpal tunnel syndrome.

The inflammatory and arthritic or degenerative discussions describedabove are usually treated with a combination of anti-inflammatory agentssuch as ibuprofen, or more powerful drugs such as steroids orchemotherapy such as methotrexate. It is a common medical practice toinject steroid medications or lidocaine directly into the inflamedtissue or joint. This is often done repeatedly. These drugs can beassociated with side effects of infection and even death from gastriculcer bleeding or immunosurpression and infection. We believe that ozonetherapy whether with oxygen-ozone mixtures or excited, energetic, pureoxygen as a gas or dissolved in a liquid has advantages over the currentpractice.

Lavage of a surgical space prior to placement of a permanent surgicalimplant such as a hip or knee prosthesis, or pacemaker or treatment ofan infected joint can be facilitated by the use of oxygen-ozone mixturesor excited, energetic, pure oxygen as a sterilizing substance. Similarlya colostomy stoma can be created such that the adhesive disk is infusedwith oxygen-ozone mixtures or excited, energetic, pure oxygen as a gasor dissolved in a liquid to aid in healing and inhibit infection. Thepost surgical recovery from sternotomy after cardiac surgery is oftencomplicated by wound infection. Placement of a resorbable catheter inthe wound that could be irrigated with oxygen-ozone mixtures or excited,energetic, pure oxygen as a gas or dissolved in a liquid would aidhealing. Indeed any wound could have a resorbable multisided holecatheter placed in it to allow oxygen-ozone mixtures or excited,energetic, pure oxygen to be injected through it. This would haveanti-infective, analgesic, and wound-healing properties therebyshortening recovery time and decreasing complication rates aftersurgery.

Endoscopic procedural infusion of ozone and trans catheter infusion ofozone can be used to inhibit the complications endoscopic medicalintervention or image guided or non-image guided catheter basedintervention for example in endoscopic evaluation of the pancreaticduct.

Dental injection of oxygen-ozone mixtures or excited, energetic, pureoxygen as a gas or dissolved in a liquid may augment the preparation andrepair of dental cavities, and aid in reduction of root canalinflammation or periodontal disease.

There are veterinary applications of minimally invasive administrationof oxygen-ozone mixtures or excited, energetic, pure oxygen as a gas ordissolved in a liquid in animals diseased with disc and degenerativesyndromes. Few other options are available in that arena. Some animalsare destroyed due to debilitating pain secondary to pain from discdisease, and arthritis.

Thus, there is a need for equipment specifically designed for thetreatment of disc herniation and other medical conditions affecting thebody with oxygen-ozone mixtures or excited, energetic, pure oxygen sothat it can be done in an efficient and sterile manner. There is a needto develop kits for intervention in inflammatory and degenerativedisease, that are portable, disposable, or reusable, but aid in creatingsterile, stable, ozone rapidly on demand.

BRIEF DESCRIPTION OF THE DRAWINGS

The present embodiments will become more fully apparent from thefollowing description and appended claims, taken in conjunction with theaccompanying drawings. Understanding that the accompanying drawingsdepict only typical embodiments, and are, therefore, not to beconsidered to be limiting of the scope of the present disclosure, theembodiments will be described and explained with specificity and detailin reference to the accompanying drawings in which:

FIG. 1 is a partially cutaway perspective view of an apparatus foradministering a therapeutic agent in accordance with an embodiment ofthe invention;

FIG. 2 is an exploded perspective view of the apparatus shown in FIG. 1;

FIG. 3 is side cross-sectional view of the material treatment module ofFIG. 1;

FIG. 4 is side cross-sectional view of another embodiment of thematerial treatment module of FIG. 1;

FIG. 5 a is a plan view of the apparatus shown in FIG. 1 in a fillposition;

FIG. 5 b is a plan view of the apparatus shown in FIG. 5 a in adispensing position;

FIG. 6 a is a cutaway plan view of an alternative embodiment of theinvention;

FIG. 6 b is cross-sectional plan view of FIG. 6 a taken along line A-A;

FIG. 6 c is detailed plan view of section B of FIG. 6 a;

FIG. 7 a is a cutaway plan view of an alternative embodiment of theinvention;

FIG. 7 b is cross-sectional plan view of FIG. 7 a taken along line A-A;and

FIG. 7 c is detailed plan view of section B of FIG. 7 a.

DETAILED DESCRIPTION OF THE INVENTION

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. While the various aspects of the embodiments arepresented in drawings, the drawings are not necessarily drawn to scaleunless specifically indicated. The scope of the invention is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

Reference throughout this specification to features, advantages, orsimilar language does not imply that all of the features and advantagesthat may be realized with the present invention should be or are in anysingle embodiment of the invention. Rather, language referring to thefeatures and advantages is understood to mean that a specific feature,advantage, or characteristic described in connection with an embodimentis included in at least one embodiment of the present invention. Thus,discussion of the features and advantages, and similar language,throughout this specification may, but do not necessarily, refer to thesame embodiment.

Furthermore, the described features, advantages, and characteristics ofthe invention may be combined in any suitable manner in one or moreembodiments. One skilled in the relevant art will recognize that theinvention can be practiced without one or more of the specific featuresor advantages of a particular embodiment. In other instances, additionalfeatures and advantages may be recognized in certain embodiments thatmay not be present in all embodiments of the invention.

Reference throughout this specification to “one embodiment,” “anembodiment,” or similar language means that a particular feature,structure, or characteristic described in connection with the embodimentis included in at least one embodiment of the present invention. Thus,appearances of the phrases “in one embodiment,” “in an embodiment,” andsimilar language throughout this specification may, but do notnecessarily, all refer to the same embodiment.

In the following description, numerous specific details are provided,such as examples of housings, barriers, chambers etc., to provide athorough understanding of embodiments of the invention. One skilled inthe relevant art will recognize, however, that the invention can bepracticed without one or more of the specific details, or with othermethods, components, materials, and so forth. In other instances,well-known structures, materials, or operations such as vacuum sourcesare not shown or described in detail to avoid obscuring aspects of theinvention.

Referring now to the FIG. 1, a handheld dispensing apparatus 10according to the present invention is shown. The apparatus 10 includes ahousing 12 that defines a chamber 14. In one embodiment, the apparatus10 or housing 12 includes a plunger 16 and a barrel 18 that define thechamber. The plunger has a first end 20 and a second end 22. The barrel18 has a first end 24 that is open for receiving the first end 20 of theplunger 16 such that the barrel 18 movably engages the plunger 16. Thebarrel 18 also includes a second end 26. In the illustrated embodiment,the first end 20 of the plunger 16 and the second end 26 of the barrel18 form the chamber 14. The housing 12 may have a volume of less thanabout 150 cubic centimeters. In one embodiment, the chamber 14 can holda volume of material up to about 150 cubic centimeters. In anotherembodiment, the chamber 14 can hold a volume of no less than about 0.1cubic centimeters. It will be appreciated that the range of volumes maycoincide with the position of the plunger 16 within the barrel 18. Forexample, the plunger 16 may move within the barrel 18 between a fillposition, where the first end 20 of the plunger 16 is within the firstend 24 of the barrel 18, but not completely within the barrel 18, and adispensing position, where the first end 20 of the plunger 16 issubstantially within the barrel 18 such that the first end 20 of theplunger 16 is adjacent the second end 26 of the barrel 18.

The chamber 14 is configured to retain a material. “Material,” as usedthroughout this specification, means gas, liquid, gels, solids, orcombinations thereof. Material may also be solids suspended or dispersedthroughout liquids, gases, or gels. A precursor or starting material maybe charged into the device to be treated by operation of the device tocreate a beneficial or therapeutic agent. Accordingly, the device 10 canbe used to create treated material that acts as a beneficial agent. Asused throughout this disclosure, “precursor,” “precursor material,” and“starting material” are used synonymously. Additionally, “treatedmaterial,” “beneficial agent,” and “therapeutic agent” may be usedsynonymously. The device is used to make a precursor material into abeneficial agent and then deliver the beneficial agent to a desiredplace, usually within a body.

In one embodiment, the first end 20 of the plunger may be configuredwith a seal 28 to facilitate retention of the material within thechamber 14. The seal may be a gasket or flexible flange or othermechanical means known in the art. It will be appreciated by those ofskill in the art that there are a variety of ways to retain materialwithin the chamber 14, each of which are within the scope of thisinvention. An outer surface 30 of the barrel 18 may include graduations32 to measure the amount of material in the chamber 14. The device 10may be configured in such a way to facilitate moving the plunger 16between the fill position and the dispensing position. For example, thebarrel 18 may include a handle finger holds 34 and the plunger 16 may beconfigured with a handle 36.

In one embodiment, the apparatus 10 includes a material treatment module40. As will be discussed in greater detail in connection with FIGS. 3and 4 below, the material treatment module 40 can take a variety ofconfigurations. The material treatment module 40 may be positionedwithin the housing 12 or the barrel 18. In one embodiment, the materialtreatment module 40 is positioned within the plunger 16. In otherembodiments, the material treatment module 40 may be positioned withinthe barrel 18. In still other embodiments, the material treatment module40 may be positioned outside the housing 12.

The material treatment module 40 is in operable communication with thechamber 14 such that precursor material in the chamber may come intocontact with, and be treated by, the material treatment module 40. Asused throughout this specification, the treating or treatment ofmaterial means to alter the composition or properties of all or aportion of the material. Similarly, “treated material” means materialthat has had its chemical composition or other properties altered ormodified. For example, in an embodiment where the precursor material isoxygen, the material treatment module 40 may an ozone generator forcreating ozone and the resulting or treated material may be a mixture ofoxygen and ozone. Similarly, where the precursor material is water, thematerial treatment module 40 may oxidize water to produce a treatedmaterial that consists of oxygen and ozone. Where the precursor materialis an aqueous salt solution, the material treatment module 40 mayoxidize the ions in the solution to create a beneficial or therapeuticagent dissolved in the solution or emitted as a gas. For example,chloride ions in a precursor material may, after interaction with thematerial treatment module 40, become chlorine gas under the reaction

2Cl⁻→Cl₂  (1)

which can then be expelled from the device into a desired location toapply its beneficial effects. Similarly, bromide ions may become bromineunder the reaction

2Br⁻→Br₂  (2)

Conversely, the material treatment module may be able to reduce theprecursor material to form the beneficial or therapeutic treatedmaterial.

It will be appreciated that the original or precursor material may betreated by the material treatment module 40 to alter a variety ofcharacteristics of the precursor material, including without limitation,the concentration of a particular element such as oxygen, the pH of thematerial, the temperature of the material, the viscosity of thematerial, and the like. The material treatment module 40 is able to takea benign material that is easy to store, and create a reactive materialthat has therapeutic value. Furthermore, treating the material may beaccomplished by a variety of methods, including without limitation,reducing the material, oxidizing the material, electrochemicallyaltering the material, chemically altering the material, thermallyaltering the material, or using light to alter the material. It will beappreciated that material treatment module the treated material may be abeneficial agent with various properties, characteristics, or attributesthat may be therapeutic to a user. The apparatus 10 allows fortransportable, single or multiple point-of-use application of thebeneficial agent.

As will be discussed in greater detail below in connection with FIG. 2,the apparatus 10 may also have means for controlling the liquid treatingmodule 40. For example, the device 20 may have an on/off switch 42 orother regulators. Additionally, the apparatus 10 may include visibleand/or audible displays or indicators 44 to help the user determine astatus of the liquid treating module. For example, the apparatus 10 mayindicating when apparatus is treating material or when it has stoppedtreating material. It may also indicate whether treated material is inthe chamber 14.

The housing 12 may have an outlet 46 in material communication with thechamber 14 for releasing the treated material from the housing 12. Inone embodiment, the outlet 46 is a port configured in the second end 26of the barrel 18. The outlet 46 may be configured to receive a needle48. For example, the outlet 46 may allow a needle 48 to be press fitinto the outlet 46. The outlet 46 may also be threaded to receive athreaded end to the needle 48. The needle 48 may be attached to theoutlet 46 by a Luer or other mechanical connection or fitting. It willbe appreciated by those of skill in the art that the outlet 46 andneedle 48 may be configured in a variety of ways in order to communicatewith each other. The needle is in material communication with the outletand thus, the chamber allows treated material to enter into the body anda specific site that will provide the most therapeutic value to theuser.

The apparatus 10 may also include a valve 50 to help control themovement of material between the chamber 14 and the needle 48. In oneembodiment, the valve is a stopcock valve. The valve may be positionedin closed state while material is being treated to prevent leakage ofthe material. Once a predetermined amount of material is treated, thevalve may be positioned in an open state to allow the treated materialto exit the apparatus 10.

Referring now to FIG. 2, a perspective exploded view of the embodimentof FIG. 1 of the present invention is shown. The apparatus 10 mayfurther include a controller 52 for controlling the amount of materialtreated by the material treatment module 40. The controller 52 in oneembodiment may include a timing circuit 54 for controlling the length oftime the material treatment module 40 is permitted to treat material. Inembodiments where the material treatment module 40 is an ozone generatorand the precursor material is oxygen or air, the controller 52 mayinclude an ozone circuit 56 for controlling the generation of ozone. Thecontroller 52 is in electrical communication with the material treatmentmodule 40. In one embodiment, the controller 52 is positioned within theplunger housing 53 and is used for controlling the amount of ozonegenerated by the material treatment module 40 which may be an ozonegenerator. It will be appreciated by those of skill in the art that thecontroller 52 may also include a relay circuit (not shown) in order forthe controller 52 to properly control the function of the materialtreatment module 40.

A power source 80 is in electrical communication with the materialtreatment module 40 and the controller 52. The power source 80 can bedirect current or alternating current. In one embodiment, the powersource 80 includes a battery or a series of batteries positionedcoaxially within the plunger 16. The controller 52 may includeelectronics capable of generating and delivering a high-voltage,high-frequency electrical signal to the material treatment module 40.The frequency of the signal can be between about one tenth of akilohertz (“kHz”) and about one thousand kHz. In one embodiment, thefrequency is between about twenty kHz and about sixty kHz. The voltageof the electrical signal is between about one kilovolt and about twentykilovolts. In one embodiment, the electrical signal is between aboutthree kilovolts and about six kilovolts. In another embodiment, thepower supply 80 can also supply an electric current with a voltagebetween about one volt and about thirty volts.

A switch 42 may be used to control the delivery of power by the powersource 80. The switch and other electrical components communicate witheach other electronically through wires or cables 60. When switch 42 isin the “on” position current is delivered to material treatment module40, and when switch 42 is in the “off” position, no current isdelivered. The switch 42 may any number of electrical switches known inthe art. For example, the switch may be a toggle that allows a user tocomplete or break the circuit multiple times. In one embodiment, theswitch is a pull tab configured such that when the pull tab is pulledout of the apparatus 10, the circuit is complete and current isdelivered to the material treatment module 40. The timing circuit 54 mayautomatically stop the generation or delivery of current at apredetermined time. The controller 52 or individual components 54 and 56of the controller 52 may also include a buzzer or light source toprovide an audible or visual signal or display to indicate whether theapparatus 10 is on or off, or status of the material treatment module40. The apparatus 10 may include a display. It will be appreciated bythose of skill in the art that the electronic components of theapparatus 40 may be hardwired to a circuit board 62 as shown, or may becontrolled by a programmable microprocessor (not shown).

The control elements and other electronics are contained with the handle36 and body of the plunger 16. The plunger 16 may include a plungerhousing 53 having a first part 64 and a second part 66. The housing 53parts 64 and 66 together form a hollow interior in which the controller52 and power source 80 are housed. An end cap 65 may be configured atthe first end 20 of the plunger 16 to help hold the interior componentsin place. The end cap 65 may be configured with a seal 28 to providesealing engagement with the interior of the barrel 18. The end cap 65may also be configured to help control the telescoping engagement of theplunger 16 within the barrel 18. The plunger housing 53 parts 64 and 66may be secured together by fastening hardware 68 known in the art suchas nuts, bolts, washers, set screws, and the like. The housing 53 halvesof the plunger 16 and other parts of the apparatus 10 such as the barrel18 may be made of molded plastic and attached together in theiroperational state. The attachment may be accomplished in a number ofways including without limitation, adhesion or other types of bonding,welding, crimping, ultrasonic coupling, thermal coupling, and the like.The housing 53 halves may also be configured to matingly engage eachother by press fitting, snap fitting, and the like. Fasteners 68 of alltypes known in the art may also be used. It will be appreciated by thoseof skill in the art that the individual components may be made andcombined in a variety of ways to practice the teachings of theinvention. In one embodiment, the electronics and control components maybe located in the barrel 18. In another embodiment, the electronics andcontrol components may be located in a separate housing or module fromthe plunger 16 or barrel 18.

The plunger 16 and barrel 18 may be made from any suitable material thatis substantially rigid, such as glass, stainless steel, polycarbonate,high density polyethylene, chlorinated polyvinylchloride, silicone,ethylene-propylene terpolymer, and fluoropolymer materials, such aspolytetrafluoroethylene, fluorinated ethylene-propylene, and the like.It will be appreciated by those of skill in the art that the materialused to make the apparatus 10 should be capable of functioning properlyin light of the particular type of material treatment being accomplishedby the material treatment module 40. For example, where the materialtreatment module 40 is an ozone generator, the plunger 16, barrel 18,and other components in contact with the material should be made of aninert material such as those listed above when exposed to ozone. Whenthe material is being treated by heat, the material should be able towithstand the range of heat being used. Similarly, when the precursormaterial is being treated by ultraviolet light, the housing must becompatible to ultraviolet light.

The material treatment module 40 may be positioned within the end 20 ofthe plunger 16. In one embodiment, the material treatment module 40 isan electrochemical cell 40 having a cathode 70, anode 72, and anelectrolyte (see FIG. 3). The chip 40 may be positioned within a cavity69 configured within plunger 16. The material treatment module 40 iscoaxial with the plunger and is open to and in communication with thechamber 14 defined by the first end 20 of the plunger 16 and the secondend 26 of the barrel 18. Furthermore, it is to be understood that thematerial treatment module 40 may be disposed at any suitable positionrelative to the housing 12 of the apparatus 10. When the housing 12 isin the form of plunger 16/barrel 18 combination, the material treatmentmodule 40 may be disposed at any suitable location between the first end20 and the second end 22 of the plunger 16, or at any location betweenthe first end 24 and the second end 26 of the interior of the barrel 18.In addition, the material treatment module 40 may also be disposed atany suitable location on an exterior surface of the device 10, or at alocation outside the device where the material treatment module 40 isunattached to, but connected to, the device.

The material treatment device 40 may also be a corona discharge device.The material treatment module 40 may also be an ultraviolet (“UV”) lightsource. In these embodiments, the power source 80, and electroniccircuits 54, 56, circuit boards 62, cables 60 and controller 52 would bemodified to allow for the proper function of the corona discharge deviceor UV light source. For example, the UV light source device, electronicswould need to provide a wavelength of the light between about 100 nm andabout 700 nm or between about 140 nm and about 200 nm.

In other aspects, the material treatment module 40 may be an open vesselfor storing an ozonated gel and a heating element, such that activationof the heating element elevates a temperature of the gel causingdesorption of ozone-oxygen mixture from the gel. The gel can be formedby sparging ozone through olive oil and then chilling the olive oil. Theolive oil is chilled to a temperature of between about minus fifteen °C. and about ten ° C. It will be appreciated by those of skill in theart that a variety of material treatment module 40 options may be usedalone or in combination to practice the teachings of this invention.

A needle 48 attached to the outlet 46 may be of any desired material,length or gauge that may be desired according to the treated materialbeing delivered. In one embodiment, the treated material is anoxygen-ozone mixture of therapeutic value, the details of which will bediscussed in greater detail below. Where an oxygen-ozone mixture isbeing delivered into a herniated disc, the needle 48 can be a Chibaneedle or Franceen needle or other suitable needle as will occur tothose of skill in the art.

Referring now to FIG. 3, a more detailed view of a material treatmentmodule 40 according to the present invention is shown. The materialtreatment module 40 may be an electrochemical cell comprising a cathode70, an anode 72, and an electrolyte 74. At least a portion of theelectrolyte 74 is positioned between the cathode 70 and the anode 72.The power source (not shown) provides voltage across the cathode 70 andthe anode 72 by means of wires 76. In this embodiment, the materialtreatment module 40 can be an electrochemical ozone generator. An oxygenor air precursor material may interact with the material treatmentmodule 40 such that an oxygen-ozone mixture is created. This mixture maybe released from the electrochemical cell configuration of the materialtreatment module 40 by the electrolysis of water and the production ofozone and oxygen at the anode 72. In one embodiment, an electric currentis used with an applied voltage between about three volts and abouttwenty volts. In another embodiment, a voltage between about two voltsand about ten volts is used.

Referring now to FIG. 4 another embodiment of the material treatmentgenerator 40 is illustrated. The material treating module 40 may be asurface-discharge corona. In this embodiment, a dielectric material 174may be positioned between a pair of electrodes 170 and 172. Wires 176may be used to connect to a discharge electrode 170 and an inductionelectrode 172. The electrodes are incorporated within a high purityalumina or silica dielectric 174. In one embodiment, the electrodes 170and 172 contain without limitation, tungsten, platinum, nichrome,stainless steel or combination thereof. When a high-frequency,high-voltage power source is applied between the two electrodes 170 and172, a stable high-frequency surface corona discharge takes place on thedischarge electrode 170. An alternative embodiment utilizes a moretraditional gap-discharge, corona material treatment module 40 thatutilizes a glass dielectric and low-frequency high voltage power. Inthis configuration, the device 10 is used to create treated gas in theform of oxidizing gas. For example, the chamber 14 (see FIG. 1) maycontain a starting gas in the form of pure oxygen gas. An oxygen-ozonemixture is released from the corona discharge device 40 by passing theoxygen-containing gas through an electrical field originating fromdevice 40 at a frequency between about one-tenth kilohertz (“kHz”) andabout one thousand kHz. In one embodiment, a frequency between abouttwenty kHz and about sixty kHz is used. An electric current with avoltage between about one kilovolt and about twenty kilovolts and a morepresently preferred voltage between about three kilovolts and about sixkilovolts may also be used.

Referring now to FIGS. 5 a and 5 b, a device 10 according to the presentinvention is illustrated. In FIG. 5 a, the device 10 is shown in a fillposition where the first end 20 of the plunger 16 is retracted to fillthe barrel 18. FIG. 5 b shows the device 10 in a dispensing position,where the first end 20 of the plunger 16 is substantially with thebarrel 18 such that the first end 20 of the plunger 16 is adjacent thesecond end 26 of the barrel 18. The range of motion of the plunger 16within the barrel 18, between the fill position and the dispensingposition, may be defined by a groove 17 configured within the plunger16. A stop 19 configured within the barrel 18 may be positioned withinthe groove 17 to control the maximum fill volume of the barrel 18. Inanother embodiment, multiple stops 19 can be incorporated to controlboth the fill and delivery volumes of the barrel 18. It will beappreciated by those of skill in the art that movement of the plunger 16within the barrel 18 may be accomplished in a variety of ways known inthe art. As stated above in connection with FIG. 1 the first end 20 ofthe plunger 16 and the second 26 of the barrel 18 form a chamber 14 oran accumulator. The chamber 14 volume decreases as the plunger is movedfrom a fill position to a dispensing position.

In use, the device 10 may be in a position such that the chamber (seenbest in FIG. 1) is capable of holding a predetermined amount ofmaterial. This precursor material, as referred throughout thespecification, may be any volume of material to be treated by thedevice. In most embodiments, it is a precursor liquid, gas, gel, orcombination thereof that will be treated by the device in order togenerate a beneficial or therapeutic agent. Precursor material may bydrawn into the chamber 14 by attaching the outlet 46 or an apparatusattached the outlet 46 such as a needle to the source of precursormaterial and drawing the plunger 16 toward the fill position. Precursormaterial may also be charged into the chamber 14 from an external sourceattached to the device 10 or distant from the device 10. Precursormaterial may be charged into the chamber 14 before packaging of thedevice or after the user has obtained the device 10. It will beappreciated by those of skill in the art that there are a number of waysto charge the device 10 or chamber 14 with precursor material. Theprecursor material may include, without limitation, air, oxygen, water,nitrogen, carbon dioxide, chlorine, bromine, and combinations thereof.It may also include a salt solution, either alone or in combination withthe foregoing. For example, the salt solution may include NaI, NaF,NaCl, NaBr, and the like. The precursor material may be in the form of agas, liquid, gel, or combinations thereof. It will be appreciated thatwhere the treated material is recycled for further treatment or furthergeneration of therapeutic agent, or where it is desirous to treat amaterial twice in order to generate a higher concentration of somebeneficial agent, then the precursor material may contain treatedmaterial.

The device 10 may then be activated by engaging a switch 42 (FIGS. 1 and2), which allows activation of the power source 80 (FIG. 2), causing thematerial treatment module 40 to interact with the precursor material inthe chamber 14. Depending upon the type of material treatment module 40being used, activation of the device 10 creates or generates beneficialagent by treating the precursor material to create a treated material.For example, where the material treatment module 40 is an ozonegenerator in the form of a corona generator, and the precursor materialis oxygen, activating the device 10 causes the material treatment module40 to emit a field that interacts with the oxygen in the chamber 14thereby creating ozone mixed with oxygen, which is a beneficial agent.Once the ozone generation cycle is complete, the plunger 16 is depressedto deliver ozone from the outlet 46. Of note, in the one embodiment thestroke of plunger 16 is chosen so that, when fully depressed, materialtreatment module 40 may come into close proximity of the second end 26of the barrel 18, but without actually coming into contact therewith.

As used throughout the specification, treated material may be materialthat has been altered or modified in any way by operation of the device10. Thus, the terms precursor material and treated material refer tomaterial at different stages of single operation of the device 10. Usingthe example above, where the precursor material is oxygen and thematerial treatment module 40 is an ozone generator, activation of thedevice 10 will create a treated material consisting of a mixture ofozone and oxygen. If this mixture were stored and later charged into thedevice for a second application, this treated mixture would then be theprecursor material for the second application of the device 10.

The treated material is the therapeutic agent desired to be delivered toa patient. The treated material may include without limitation, ozone,oxygen, nitric oxide(s), chlorine, fluorine, chlorine dioxide, iodine,carbon dioxide, bromine, bromine dioxide, oxygen radicals; hydroxylradicals; ionic oxygen; oxygen treated with energy and combinationsthereof. At least a portion of the treated material may also includeprecursor material. The treated material may also include inert gaseswhich can include, but are not limited to, nitrogen, helium, carbondioxide, and/or combinations thereof.

Referring now to FIG. 6 a, another embodiment of the device 310 isillustrated. The device 310 includes a plunger 316 and a barrel 318 thatdefine a chamber 314 for holding precursor material. The plunger 316 hasa first end 320 and a second end 322. The barrel 318 has a first end 324that is open for receiving the first end 320 of the plunger 316 suchthat the plunger 316 movably engages the barrel 318. The barrel 318 alsoincludes a second end 326. The second end 326 of the barrel 318 may beconfigured with an outlet 346 that serves as the outlet 346 for thechamber 314. A needle 348 may include a first end 382 and a second end384. The second end 384 of the needle 348 may be attached to the outlet346 using a Luer or other mechanical connection or fitting.

In this embodiment, the material treatment module 40 is within theneedle 348 or is the needle 348 itself. As can best be seen in FIG. 6 b,a cross sectional view of FIG. 6 a taken along line A-A, and FIG. 6 c, ablown up view of area B, the needle 348 utilizes a flow-throughelectrochemical cell to create treated material in the form of atherapeutic agent. The electrochemical cell needle 348 includes an anode370 and a cathode 372. Electric current is delivered to the anode 370and cathode 372 by wires 376 attached to a power source 380. The chamber314 is charged with precursor material or precursor or electrolyte (notshown). As with other embodiments disclosed herein, the electrochemicalreaction between the material treatment module 340 and the precursormaterial can be controlled by the selection of electrode or electrolytematerial. The electrodes 370 and 372 affect the electrochemical kineticsof the electroxidation/electroreduction reaction at the electrode 370and 372.

The power source is initiated to polarize the anode 370 and cathode 372which generates therapeutic agent by electrooxidizing or electroreducingthe precursor material as it is plunged out the chamber 314 and into theneedle 348. In another embodiment, the anode 370 is the metallic wall ofthe needle. The anode 370 and cathode 372 may be reversed for allembodiments. As discussed above, the timing and control of the appliedvoltage and/or current power source control the amount of beneficialagent that is produced by the material treatment module 40, and may bemanual or automatic (i.e. programmable microprocessor controlled).

It will be appreciated by those of skill in the art that for ease ofoperations, the wires can be conductors that are printed on the insideof the chamber 314. In one embodiment the wires 376 are insulated andthe electrodes 370 and 372 are conductive and selective for the desiredbeneficial agent. For gas precursors, the electrodes 370 and 372 may betungsten, platinum, stainless steel, nichrome, or aluminum configured inthe needle 348. It will be appreciated that the material treatmentmodule 40 in the needle 348 configuration may also be set up as coronadischarge device in a manner similar to a traditional gap-discharge,corona discharge devices. In this configuration, the needle would gastreating module that utilize a glass dielectric on the high-voltageelectrode and would be powered by low-frequency, high-voltage power. Forliquid precursors, similar electrodes are used, however they are poweredby low voltages, and do not require a dielectric like the high voltageelectrodes.

Referring now to FIG. 7 a, another embodiment of the device 410according to the present invention is shown. The device 410 includes aplunger 416 and a barrel 418 that define a chamber 414 for holdingprecursor material. The plunger 416 has a first end 420 and a second end422. The barrel 418 has a first end 424 that is open for receiving thefirst end 420 of the plunger 416 such that the plunger 416 movablyengages the barrel 418. The barrel 418 also includes a second end 426.The second end 426 of the barrel 418 may be configured with an outlet446 that serves as the outlet 446 for the chamber 414. A needle 448 mayinclude a first end 482 and a second end 484. The second end 484 of theneedle 448 may be attached to the outlet 446 using a Luer or othermechanical connection or fitting.

In this embodiment, the material treatment module 40 is the needle 448.As can best be seen in FIG. 7 b, a cross sectional view of FIG. 7 ataken along line A-A, and FIG. 7 c, a magnified view of area B, theneedle 448 utilizes a flow-through electrochemical cell to createtreated material in the form of a therapeutic agent. The electrochemicalcell needle 448 includes an anode 470 and a cathode 472. Electriccurrent is delivered to the anode 470 and cathode 472 by wires 476attached to a power source 480. The chamber 414 is charged withprecursor material or precursor or electrolyte (not shown).

In this embodiment, the needle 480 houses electrodes 470 and 472 thatare used to produce a beneficial agent in situ, or in other words,within the body. In this embodiment, additional electrolyte may or maynot be supplied in chamber 414. The electrodes 470 and 472 extend beyondthe opening 486 to have greater access to body fluid for generating insitu treated material which can be a beneficial agent. It will beappreciated that the plunger 416/barrel 418 configuration is notnecessary for this application because the treated material is generatedbeyond the end 486 of the needle 448. However, the syringe-typeconfiguration may be desirable to provide additional saline solution orother liquid precursors by plunging of the plunger 416 into the barrel418 for patients that are dehydrated or to areas of the body that don'thave much material. The first end 482 of the needle may have aprotective shield or shroud (not shown) that protects the electrodes 470and 472 from being damaged upon insertion.

A method of dispensing a material using a handheld dispensing apparatusis also disclosed. A dispensing apparatus or device 10, 310, 410, asdiscussed above may be used to dispense the material. The methodincludes collecting a precursor material in the chamber 14, 314, 414.The material treatment module 40, 340, 440 is activated. The precursormaterial collected in the chamber 14, 314, 414 is treated by thematerial treatment module to create a treated material. The needle 48,348, 448 is positioned within a body. The treated material is thendispensed out of the device 10, 310, 410 or chamber into the bodythrough the needle.

In one embodiment, the precursor material may include, withoutlimitation, air, oxygen, water, nitrogen, carbon dioxide, chlorine,bromine, iodine, flourine and combinations thereof. It may also includea salt solution, either alone or in combination with the foregoing. Forexample, the salt solution may include NaI, NaF, NaCl, NaBr, and thelike. It will be appreciated by those of skill in the art that the termsalt solution includes compounds formed when the hydrogen of an acid isreplaced by a metal.

Activating the material treatment module 40 includes engaging a switchto allow power from a power source to be delivered to the materialtreatment module. The method may also include deactivating the materialtreatment module, either manually or automatically. The method may alsoinclude detecting an amount of material treated by the materialtreatment module to determine when to shut off the module 40 or device10. This may be accomplished by monitoring a display.

In embodiments, where the housing is a syringe configuration with aplunger 16, 316, 416 movably engaged within a barrel 18, 318, 418,dispensing the material may include moving the plunger relative to thebarrel such that treated material is delivered through the needle intothe body.

Without further elaboration, it is believed that one skilled in the artcan use the preceding description to utilize the present disclosure toits fullest extent. The examples and embodiments disclosed herein are tobe construed as merely illustrative and not a limitation of the scope ofthe present disclosure in any way. It will be apparent to those havingskill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure provided herein. In other words, variousmodifications and improvements of the embodiments specifically disclosedin the description above are within the scope of the appended claims.Note that elements recited in means-plus-function format are intended tobe construed in accordance with 35 U.S.C. §112 ¶6. The scope of theinvention is therefore defined by the following claims.

1. A method of dispensing a material using a handheld dispensingapparatus, the dispensing apparatus comprising a housing defining achamber, a material treatment module in material communication with thechamber, an outlet in material communication with the chamber, and aneedle in material communication with the outlet for releasing thematerial from the housing, the method comprising: collecting a precursormaterial in the chamber; activating the material treatment module;treating the precursor material collected in the chamber with thematerial treatment module to create a treated material; positioning theneedle in a body; and dispensing the treated material out of theapparatus into the body.
 2. The method of claim 1, wherein the precursormaterial comprises one of the group consisting of air, oxygen, water,salt solution, nitrogen, carbon dioxide, fluorine, chlorine, bromine,iodine, and combinations thereof.
 3. The method of claim 1, wherein atleast a portion of the treated material comprises one of the groupconsisting of: ozone, oxygen, oxygen radicals, oxygen treated withenergy, hydroxyl radicals, ionic oxygen, nitric oxide, chlorine,fluorine, chlorine dioxide, nitrogen, helium, iodine, carbon dioxide,bromine, bromine dioxide, and combinations thereof.
 4. The method ofclaim 1, wherein at least a portion of the treated material comprisesprecursor material.
 5. The method of claim 1, wherein activating thematerial treatment module comprises engaging a switch to allow powerfrom a power source to be delivered to the material treatment module. 6.The method of claim 1, further comprising deactivating the materialtreatment module.
 7. The method of claim 1, further comprising detectingan amount of material treated by the material treatment module.
 8. Themethod of claim 7, wherein detecting an amount of material comprisesmonitoring a display.
 9. The method of claim 1, wherein the housingcomprises a barrel movably attached to a plunger.
 10. The method ofclaim 9, wherein dispensing the material further comprises moving theplunger relative to the barrel such that treated material is deliveredthrough the needle into the body.
 11. A method of dispensing ozone usinga handheld dispensing apparatus, the dispensing apparatus comprising ahousing defining a chamber configured to hold oxygen, a corona dischargeassembly in communication with the chamber to create ozone from theoxygen, a power supply in electronic communication with the coronadischarge assembly, said power supply external to the housing, an outletin material communication with the chamber, the method comprising:collecting oxygen in the chamber; placing the chamber in operablecommunication with the corona discharge assembly; activating the coronadischarge assembly; treating the oxygen collected in the chamber with acorona discharge to create ozone; and delivering the ozone from thechamber.